Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training (Mental-AF)

Helios Health Institute GmbH

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Meditation; Persistent Atrial Fibrillation

Treatments: Other: Mental training

Study type: Interventional

Funder types: Other

Identifiers

NCT04067427

MAF2019

Details and patient eligibility

About

Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.

Full description

To explore the potential of a daily app-based mindfulness mental training in improving AF symptoms, assessed by self-reported outcome measures, i.e. the AF 6 questionnaire, AF Effect on QualiTy of Life (AFEQT) and Patient Reported Outcome Measurement Information System (PROMIS) Global Health questionnaires, as well as in reducing AF burden in 7-day-Holter, within the first 12 weeks following AF ablation.

Enrollment: 183 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing AF ablation with symptomatic paroxysmal or chronic atrial fibrillation (EHRA II-IV)
• Availability of smart phone with the capability to run android 5 or iOS 9 or newer versions
• Capability to use mobile phone applications
• Internet access
• Consent to study participation

Exclusion criteria

• Patients < 18 years of age
• Unavailability of smart phone running at least Android 5 or iOS 9
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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183 participants in 2 patient groups

Mental training

Active Comparator group

Description:

AF ablation followed by 3 months of a daily app-based mental training for 10 to 15 minutes per session. AF 6 questionnaire will be answered weekly via the Mental-AF webpage.

Treatment:

Other: Mental training

Control

No Intervention group

Description:

AF ablation without subsequent mental training. AF 6 questionnaire will be answered weekly via the Mental-AF webpage.